Kornimate/medical-research-clean huggingface dataset:
is life worth living after major emergency gi surgery? patient reported outcome in elderly emergency surgery patients

Conditions: Emergency; Surgery

Summary: to study the impact of emergency high risk gi surgery on hrqol in elderly patients, seventy-five years or above and to explore the patients' experience with the informed consent process and the status 6 months after surgery.

we will identify all patients aged ≥ 75 having an emergency gi laparotomy or laparoscopy between the 1st of november 2014 and the 30st of april 2015. the first part of the study will take place in the first postoperative week, while the patient is in hospital. after consent we will ask both patient and relatives/caregivers questions concerning the preoperative course and the informed consent. we will ask for permission to call the patients for a followup (the second part of the study) 5-7 months after discharge and permission to contact their closest relative. the closest relative is chosen by the patient and will after consent be asked the same questions in the first postoperative week and after 6 months. the second part of the study will be initiated with a letter with sf-36 and an additional questionnaire . the sf-36 will be returned by letter. we will contact the patients by telephone 2 weeks after sending the letter ask them the questions from the additional questinaire. we will compare the results from the sf-36 with age-matched controls (data from the danish sf-36 manual). if the patient is not capable of answering the questionnaires, the primary reason is noted (e.g. suffering from dementia or didn't speak danish, dead). we will aim at a 6 month follow-up period after discharge allowing a range from 5-7 months. data acquisition will be done in the fall 2014 until late 2015.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 75 having an emergency gi laparotomy or laparoscopy between the 1st of november 2014 and the 30st of april 2015. we will also include reoperations after elective surgery (major bleeding, anastomotic leakage etc.) and endoscopic procedures converted during the intervention (upper gi-bleeding, unsuccessful stenting of obstructing colorectal cancer etc.). exclusion criteria: * appendectomies, negative laparoscopy/laparotomy, laparoscopic cholecystectomy, acute hernias without strangulation, sub-acute internal hernia after roux-en-y gastric bypass surgery, sub-acute ibd-surgery and sub-acute colorectal cancer-surgery. sub-acute is defined as planned in less than 48 hours.

Keywords: emergency surgery hrqol elderly
efficacy and safety of obeticholic acid in the treatment of primary biliary cholangitis

Conditions: Primary Biliary Cholangitis

Summary: obecholic acid is a modified bile acid and farnesoid x receptor (fxr) agonist. fxr is a key regulator of bile acid synthesis and transport. bile acids are used by the body to help with digestion. conventional therapy with obecholic acid will improve liver function of patients with (primary biliary cholangitis)pbc. the main objectives of the study were to assess the effects of obeticholic acid (oca) on serum alkaline phosphatase (alp) and total bilirubin, together as a composite endpoint and on safety in participants with pbc.


Eligibility criteria:
inclusion criteria: 1. age ≥18 and ≤75 years； 2. definite pbc diagnosis, as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors: ① indicators reflecting cholestasis such as elevated alp；② positive antimitochondrial antibody (ama) or ama-m2, or positive pbc-specific antibody (anti-gp210 and/or anti-sp100) if ama negative；③ liver biopsy consistent with pbc； 3. at least 1 of the following qualifying biochemistry values: ① alp ≥ 1.67x uln ；② total bilirubin \> uln but \< 2x uln； 4. taking udca for at least 6 months (stable dose for ≥ 3 months) prior to day 0, or unable to tolerate udca (no udca for ≥ 3 months) prior to day 0； 5. understand the study, comply with the study protocol, and voluntarily sign the informed consent form. exclusion criteria: 1. patients who took obeticholic acid within 3 months prior to day 0; 2. known hypersensitivity to obeticholic acid, ursodeoxycholic acid; 3. history or presence of other concomitant liver diseases; 4. cirrhosis-related complications or end-stage liver disease manifestations; 5. serum creatinine (cr) ≥ 1.5 × uln and serum creatinine clearance \< 60 ml/min; 6. patients with severe pruritus or requiring systemic drug therapy within 2 months prior to day 0; 7. patients with hiv or syphilis infection; 8. presence of diseases or physiological conditions that interfere with the absorption, distribution, metabolism or excretion of test drugs, such as inflammatory bowel disease and previous gastric bypass surgery; 9. presence of diseases that may cause non-hepatogenic alp elevation, or diseases that may lead to a life expectancy of less than 2 years; 10. administration of the following drugs within 6 months prior to day 0: azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate mofetil, pentoxifylline; fenofibrate or other fibrates; budesonide and other systemic corticosteroids; hepatotoxic drugs (including α-methyldopa, sodium valproate, isoniazid, nitrofurantoin, etc.); 11. administration of the following drugs within 12 months prior to day 0: antibodies or immunotherapy against interleukins or other cytokines or chemokines; 12. patients with serious cardiovascular system, digestive system, respiratory system, urinary system, nervous system, mental illness, immunodeficiency disease, and judge by investigators that they are not suitable for participating in the trial; 13. other conditions that are not considered appropriate by the investigator.
eradicating cervical cancer in kenya

Conditions: Human Papilloma Virus; HIV Infections

Summary: this is a study of a strategy designed to 1) increase cervical cancer screening using a community-based approach, and 2) determine the efficacy of hpv vaccination in a region of kenya where half of all children are chronically exposed to aflatoxin.

cervical cancer is caused by oncogenic hpv, and is the main cause of cancer-related death among kenyan women. this malignancy is preventable through a combination of screening of adult women and vaccination of children and adolescents against hpv infection. however, only 5% of kenyan women are regularly screened, and only 14% have ever been screened, which in kenya is done by a method known as visual inspection with acetic acid (via). obstacles to screening include travel to clinics, costs, poor specificity of via, lack of trained personnel, and others. in addition, while safe and effective hpv vaccines have been available for 15 years, very few (\<1%) kenyan children and adolescents have been vaccinated. obstacles to vaccination include costs, delivery infrastructure, lack of education, travel to clinics, and others. in addition, there are few studies of hpv vaccination in african children, and two-dose regimens may not provide adequate protective antibody levels among children chronically exposed to aflatoxin, a potent immunosuppressive agent found in contaminated corn. investigators propose a study of a strategy designed to 1) increase cervical cancer screening using a community-based approach, and 2) determine the efficacy of hpv vaccination in a region of kenya where half of all children are chronically exposed to aflatoxin. objective 1 (cervical cancer screening): evaluate high-risk (hr)-hpv dna testing of self-collected vaginal swabs as a triage step for via among rural kenyan women. hypothesis: all women with negative hr-hpv dna tests will have normal via examinations or falsely-abnormal via examinations based on cervical biopsy results. the rationale is that if this hypothesis is correctly proven, it will suggest that via is unnecessary for women with negative hr-hpv dna tests in self-collected vaginal swabs. objective 2 (hpv vaccination): determine the effects of chronic aflatoxin exposure among kenyan children/adolescents on the likelihood of seroconversion to hpv types represented in the hpv vaccine. hypothesis: compared to children/adolescents without detectable plasma aflatoxin, children/adolescents with evidence of chronic aflatoxin exposure will have a reduced likelihood of seroconversion to hpv types represented in the hpv vaccine. the rationale is that if this hypothesis is correctly proven, it will suggest that adjustments in vaccination doses/schedules may be needed for children with chronic exposure to aflatoxin to assure adequate protection against hpv infection.

Eligibility criteria:
inclusion criteria: * kenyan women between ages of 18 and 60 years and children/grandchildren aged 9 through 18 of women attending the community meetings. exclusion criteria: pregnancy, history of cervical cancer, allergy to hpv vaccine (children) -

Keywords: hpv hiv kenya
topical nvn1000 for the treatment of external genital and perianal warts

Conditions: Genital Warts; Perianal Warts

Summary: a phase 2 multi-center, double-blind, randomized, vehicle-controlled, ascending dose study assessing tolerability, safety, and efficacy of topical nvn1000 in subjects with external genital warts and perianal warts

this is a phase 2, multi-center, randomized, double-blind, vehicle-controlled, ascending dose study to assess safety, tolerability and efficacy of a topical nitric oxide releasing compound in subjects with external genital and perianal warts. eligible subjects will be treated with a topical gel (active or vehicle) for up to 12 weeks.

Eligibility criteria:
inclusion criteria: * at least 2 but not more than 20 genital/perianal warts with a maximum total wart surface area no more than 1% body surface area * if a woman of child-bearing potential, have a negative pregnancy test and use effective contraception * if currently receiving wart treatment, be willing to stop all treatment for 28 days prior to randomization and during the study exclusion criteria: * immunocompromised patients including those with hiv, receiving radiation, or drugs that suppress the immune system * pregnant, planning to become pregnant, or nursing * history of cancer (including cervical cancer) within 5 years, with exception of non-melanoma skin cancer in non-genital skin * recent history of other genital skin infections * active hsv and frequent hsv recurrences unless receiving suppression therapy * have hemoglobin \ 3% * known allergy to any component of the gel including excipients * previously participated in any study with nvn1000 or sb204

Keywords: genital warts perianal warts
68ga-psma pet in diagnosing metastasis in patients with ovarian cancer

Conditions: Ovarian Carcinoma

Summary: this trial studies how well gallium ga 68-labeled prostate specific membrane antigen (psma)-11 (68ga-psma) positron emission tomography (pet) works in patients with ovarian cancer to detect whether the tumor has spread to other places in the body. 68ga-psma is a radioactive substance that binds to blood vessels around the ovarian cancer and can be imaged using pet. diagnostic procedures, such as pet, may help find and diagnose find out how far the disease has spread.

primary objectives: i. to determine the feasibility and utility of 68ga-psma pet imaging patients with ovarian cancer. ii. determine detection sensitivity for nodal metastases for psma pet stratified by node size. secondary objectives: i. to assess the correlation between targeted molecular uptake of 68ga-psma pet and psma expression in surgical resection specimens. exploratory objectives: i. to explore heterogeneity of 68ga-psma pet uptake in cases of metastatic ovarian cancer. ii. to determine the relationship between 68ga-psma pet uptake, diffusion weighted imaging, and mri-derived tumor perfusion. outline: patients receive gallium ga 68-labeled psma-11 intravenously (iv) over 1-2 minutes. after about 60 minutes, patients undergo pet/magnetic resonance imaging (mri) for approximately over 50-60 minutes. patients may undergo an optional repeat gallium ga 68-labeled psma-11 pet between 8 and 12 weeks after completion of the first pet/mri. after completion of study, patients are followed up at 28 days.

Eligibility criteria:
inclusion criteria: 1. patients with one of the following, identified on prior imaging (ct, mri or ultrasound): 1. adnexal mass 2. abdominal or pelvic tumor suspicious for ovarian cancer metastases (either suspected on clinical grounds, or known from prior tissue sampling) 2. female, 3. age \>= 18 years 4. creatinine \</= 1.5 mg/dl 5. ability to understand a written informed consent document, and the willingness to sign it exclusion criteria: 1. pregnant or breastfeeding women 2. patient unlikely to comply with study procedure, restrictions and requirements and judged by the investigator to be unsuitable for study participation.
concomitant tricuspid repair in patients with left heart surgery

Conditions: Tricuspid Regurgitation; Mitral Regurgitation; Cardiopulmonary Bypass

Summary: tricuspid regurgitation is common in patients with severe left heart diseases, such as degenerative mitral regurgitation. however, the evidence base is insufficient to inform a decision about whether to perform concomitant tricuspid-valve repair during left heart surgery in patients who have mild tricuspid regurgitation. to inform decision making, we will conduct a multicenter, randomized trial to assess the benefits and risks of tricuspid-valve repair at the time of left heart diseases in patients with mild tricuspid regurgitation who were undergoing surgery for left heart surgery.


Eligibility criteria:
inclusion criteria: 1. patients undergoing left heart valve surgery with mild tricuspid regurgitation; 2. patients aged 18-80 years; 3. agree to participate in this study and sign the informed consent form. exclusion criteria: 1. infective endocarditis within 3 months; 2. primary tricuspid regurgitation; 3. isolated tricuspid regurgitation 4. lactating women and suspected pregnant or pregnant women; 5. patients with mental disorders, drug and alcohol dependence; 6. those who participated in other clinical trials one month before the trial; 7. refusal to participate in this study without informed consent.
keeping weight off: brain changes associated with healthy behaviors

Conditions: Overweight; Obesity

Summary: the goal of this project is to characterize changes in emotion regulation pathways associated with healthy behaviors in people who have recently lost weight and are seeking to maintain weight loss over a 1-year period.

unhealthy behaviors such as overeating and a sedentary lifestyle are largely responsible for overweight and obesity which substantially increase risk for chronic conditions such as heart disease, high blood pressure, stroke, diabetes, arthritis and certain cancers. the rapid rise in obesity threatens to reverse recent gains in life expectancy and account for a large percentage of premature deaths in the u.s. although there is evidence for the short-term efficacy of a number of methods for initiating health behavior change to lose weight, these interventions have shown only limited ability to affect significant, long-term behavioral changes in the majority of adults. in part this may be because they fail to adequately address how psychological factors that lead to relapse to unhealthy behaviors and failure to maintain long-term behavior change. the purpose of the study is to understand brain changes that accompany participation in programs that foster healthy behaviors in people seeking to maintain weight loss. we will use mri scans to study brain function in men and women 25-60 years old who have lost weight in the last year without surgery. participants will be assigned to one of two programs to help them maintain weight loss and will be compensated for their time. our goal is to gain a better understanding of the brain changes that lead to long-term success in keeping weight off, in the hope that this knowledge will assist in the development of improved treatments.

Eligibility criteria:
inclusion criteria: * 25 to 60 years old * healthy individuals who have intentionally lost at least 5% of their body weight over the past year * bmi \>20.5 kg/m2 at study entry and \>25 in past 2 years exclusion criteria: * weight-loss surgery or medications * serious psychiatric or medical conditions * substance abuse * ineligible for mri * pregnant * eating disorder

Keywords: weight loss body weight changes body weight magnetic resonance imaging emotions emotion regulation health behavior eating behavior
zuojin wan combined with woonosan fumarate for the treatment of grd combined with depression

Conditions: Gastroesophageal Reflux Disease; Depression

Summary: to evaluate the improvement of symptoms in patients with gastroesophageal reflux disease combined with depression (hepatic and gastric depression-heat type) by zuojin wan combined with vornodine fumarate regimen as a control, and to compare the adherence to the medication and the adverse reactions of the patients between the two groups.

gastroesophageal reflux disease (gerd) is a common digestive disorder, and in recent years studies have shown an increasing incidence of comorbid depression in patients with gerd. the treatment of gastric acid inhibition and mucosal protection alone is not effective for patients with reflux combined with depression, and the additional administration of neuromodulatory drugs will increase the incidence of adverse reactions, so the combination of traditional chinese medicine may be one of the effective ways to solve the above problems. the aim of this study was to compare the efficacy of zuojin wan combined with vunorasan fumarate with that of vunorasan fumarate alone.

Eligibility criteria:
inclusion criteria: 1. aged between 18 and 65 years; 2. fulfilment of western medical diagnostic criteria for gerd; 3. meet the diagnostic criteria for mild depression; 4. comply with the diagnostic criteria of liver and stomach depression-heat syndrome in chinese medicine; 5. a score of 7-17 on the 17-item hamilton depression scale (hamd-17) (7-17 being mild depression); 6. good compliance and autonomous behaviour; 7. no medications that may have an effect on the study, such as acid-suppressing agonists, were taken within 2 weeks prior to enrolment; exclusion criteria: 1. hp positive patients; 2. other organic diseases of the digestive system, such as peptic ulcer, peptic tumour, peptic haemorrhage, liver, gallbladder and pancreas disease, intestinal obstruction and inflammatory bowel disease; 3. systemic diseases affecting the dynamics of the digestive tract, such as diabetes mellitus, chronic renal insufficiency, connective tissue diseases, neurological lesions, etc; 4. pathological diagnosis of the esophageal mucosa suggestive of moderate-to-severe heterogeneous hyperplasia; 5. previous surgery resulting in a decrease in gastric acid or a history of oesophageal or gastric surgery; 6. varicose veins in the esophagus or fundus of the stomach; 7. persons with severe primary heart, brain, liver, lung, kidney, blood or serious disease affecting their survival; 8. those with depression, suicidal tendencies and mental disorders who cannot cooperate; 9. pregnant or breastfeeding women, or patients who have a plan to have children in the near future; 10. taking drugs that have an effect on the results of this study within 2 weeks before participating in this study; 11. allergy or adverse reaction to the study drug.
comparison of two identical nn1250 formulations in healthy volunteers

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this clinical trial is to investigate if two identical formulations of nn1250 (insulin degludec, ideg) have the same level of drug exposure to the body.


Eligibility criteria:
inclusion criteria: * considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ecg), as judged by the investigator * body mass index 18.0-27.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period * female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner)
clinical outcomes of patients treated with open surgical repair for complex aortic aneurysms

Conditions: Aortic Aneurysm, Abdominal

Summary: this is a prospective, non-randomized, single center, data collection study of patients treated with open surgical repair (or) for complex aortic aneurysms (caas).

patients in need of or for caas will be placed in this prospective, non-randomized, single center, data collection study. choice of the prosthetic graft and configuration will be based on surgeon's preference and extent of the disease. or will be performed by vascular surgeons at mayo clinic, rochester, assuming no difference in surgical techniques. demographics, clinical presentation, preoperative clinical and imaging assessment, intraoperative information, length of icu stay and hospitalization, early and late mortality, major adverse events (maes), reintervention, rupture and qol at different postoperative time points (4 months, 1 year, 3 years and 5 years) will be recorded according to well-designed case report forms (crfs) and sf-36 form. follow-up information will be obtained from office visits or mailing questionnaires (sf-36 form and caa-specific questionnaire). patients will be asked to fill out the sf-36 forms preoperatively, and along with the caa-specific questionnaire at 4 months, 1 year, 3 years and 5 years post-operatively. physician assistants or study coordinators will interview all patients prior to treatment (during office evaluation). the follow-up assessments will be conducted by questionnaires (sf-36 and caa-specific questionnaire) and office visits as well. if no response in 6 weeks after sending out questionnaires at each time point, telephone interview will be followed.

Eligibility criteria:
inclusion criteria: patients undergoing elective, emergent or urgent or for caas, including: 1. abdominal aortic aneurysms (aaa) not eligible for endovascular aneurysm repair (evar), including 1) infrarenal aaa with complex aneurysm morphology 2) short neck infrarenal aaa 3) juxtarenal aaa 4) suprarenal aaa 2. thoracoabdominal aortic aneurysms (taaa) (type i - iv) 3. chronic aortic dissections exclusion criteria: 1. patients who refuse to participate the study 2. patients age \< 18 years 3. pregnant breastfeeding patients